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U.S. Department of Health and Human Services

Class 2 Device Recall IILICO MIS Posterior Spinal Fixation System

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 Class 2 Recall
IILICO MIS Posterior Spinal Fixation System
see related information
Date Posted March 18, 2013
Recall Status1 Terminated on March 20, 2013
Recall Number Z-0967-2013
Recall Event ID 55155
Premarket Notification
510(K) Number
K042673 
Product Classification Appliance, Fixation, Spinal Interlaminal - Product Code KWP
Product ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO® MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
Code Information Lot # 635436; Part #73601-110
Recalling Firm/
Manufacturer
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, California 92008-8816
Manufacturer Reason
for Recall
The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Alphatec Spine sent an Urgent Medical Device Recall letter dated July 6, 2011, to all affected customers. This notification described the product, problem and actions to be taken. The consignees were instructed to review their inventory to verify the affected device; abstain from use; immediately contact Alphatec Spine Sales Administration (salesadministration@alphatecspine.com) for instructions on how to return this affected product; and complete, sign and return confirmation form to Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad, CA 92008. If you have any questions, call 760-431-9286.
Quantity in Commerce 7
Distribution Worldwide Distribution - USA including CO and NC; Internationally to Belgium.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = ALPHATEC/NEXMED
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